UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`DEPUY SYNTHES SALES, INC. and DEPUY
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`SYNTHES PRODUCTS, LLC,
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`Petitioner
`
`v.
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`Patent Owner of
`U.S. Patent No. 6,099,531 to Bonutti
`Appl. No. 09/137,443 filed Aug. 20, 1998
`Issued Aug. 8, 2000
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`IPR Trial No.
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`TBD
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`DECLARATION OF CARL R. McMILLIN, Ph.D., IN SUPPORT OF
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO.
`6,099,531 PURSUANT TO 35 U.S.C. § 312 AND 37 C.F.R. § 42.108
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`1 of 48
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`DEPUY SYNTHES SALES, INC. and DEPUY
`
`SYNTHES PRODUCTS, LLC,
`
`Petitioner
`
`v.
`
`Patent Owner of
`U.S. Patent No. 6,099,531 to Bonutti
`Appl. No. 09/137,443 filed Aug. 20, 1998
`Issued Aug. 8, 2000
`
`IPR Trial No.
`
`TBD
`
`DECLARATION OF CARL R. McMILLIN, Ph.D., IN SUPPORT OF
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO.
`6,099,531 PURSUANT TO 35 U.S.C. § 312 AND 37 C.F.R. § 42.108
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`1 of 48
`
`
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`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
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`1.
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`2.
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`I, Carl. R. McMillin, Ph.D., declare as follows:
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`I understand that DePuy Synthes Sales, Inc. and DePuy Synthes
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`Products, LLC (collectively “Synthes”) are petitioning for inter partes review of
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`U.S. Patent No. 6,099,531 (“the ‘531 patent”) and the cancellation of Independent
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`Claim 105 (“the Challenged Claims”) of the ‘531 patent. I submit this declaration
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`in support of the Synthes petition.
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`3.
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`I understand that the ‘531 patent issued on August 8, 2000, from an
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`application which claims priority to August 20, 1998. My statements and opinions
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`in this declaration are intended to reflect the knowledge in the art that existed as of
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`August 20, 1998
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`4.
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`I am being compensated for my time at my standard rate of $500 per
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`hour plus expenses. My compensation is not dependent in any way upon the
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`outcome of the Synthes petition
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`
`I.
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`PROFESSIONAL BACKGROUND
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`5.
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`I am currently an Independent Consultant and President of Synthetic
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`Body Parts, Inc. in Brecksville, Ohio. I have held this position since 1997. From
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`1989-1997, I held positions as Senior Scientist, Director of Polymer Laboratory
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`and Director of R&D at AcroMed Corporation in Cleveland, Ohio. From 1983-
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`1989, I was an Associate Professor in the Department of Biomedical Engineering
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`and Director of the Cardiovascular Laboratory in the Institute for Biomedical
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`
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`1
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`2 of 48
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`
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`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
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`Engineering Research at the University of Akron where I taught graduate level
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`courses in Biomaterials and Artificial Organs and Medical Devices. From 1975-
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`1983, I was a Contract Manager and Senior Research Chemist at Monsanto
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`Research Corporation at the Dayton Laboratory in Dayton, Ohio.
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`6.
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`I am also currently a member of the adjunct faculty at Cleveland State
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`University and have taught courses in Biomaterials, Artificial Organs and Medical
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`Devices, and Cardiovascular Complications of Diabetes in the doctoral Applied
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`Biomedical Engineering Program. I have been a member of the University’s
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`adjunct faculty since 1999.
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`7.
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`I obtained my Bachelors of Mechanical Engineering in 1969 from the
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`General Motors Institute of Technology (Major Material Science). I received my
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`Master of Science in Macromolecular Science from Case Western Reserve
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`University. I subsequently received my Doctorate of Philosophy from Case
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`Western Reserve University in Macromolecular Science (Major) and Operations
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`Research (Minor) in 1974 and was a Postdoctoral Fellow on a grant from the
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`National Heart, Lung and Blood Institute of the National Institutes of Health for a
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`year.
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`8. My work as an Independent Consultant at Synthetic Body Parts, Inc.
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`relates to biomedical product development and biomaterials for both start-up
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`companies and multi-national companies and as an expert in patent and medical
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`
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`2
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`3 of 48
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`
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`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
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`implant failure litigation.
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`9.
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`In my roles as Senior Scientist, Director of the Polymer Laboratory
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`and Director of R&D at AcroMed Corporation, I conducted and directed research,
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`development, evaluation and commercialization of many metal, polymer,
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`polymer/carbon fiber composite and elastomer material based orthopedic products,
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`primarily for the spine.
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`10.
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`I am the Recipient of the 2015 C. William Hall lifetime achievement
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`award from the Society for Biomaterials “For significant contributions to the
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`Society for Biomaterials and an outstanding record in establishing, developing,
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`maintaining, and promoting the objectives and goals of the Society,” received on
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`April 2015, Charlotte, NC. I was a Delegate on the first People-to-People program
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`on Biomaterials to the Peoples Republic of China (October 26 to November 6,
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`2010). I am a volunteer Scientific Member of the Institutional Review Board for
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`Human Protection (IRB) for the University Hospitals Case Medical Center of
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`Cleveland; I have been an IRB member since June 2005. I was a member of the
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`Edison Biotechnology Center, Omeris (State of Ohio) from 1992 through 2002, the
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`Commercialization Cabinet from 1997-2002, the Scientific Advisory Council from
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`1992 through 1994, and the Executive Advisory Committee from 1992-1996. I
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`was also a member of the External Advisory Board at the Center for
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`Cardiovascular Biomaterials, Case Western Reserve University, Cleveland, OH,
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`3
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`4 of 48
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`
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`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
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`from 1994 through 1998. I was also an Executive Editor (U.S.A.) of the
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`international journal, Bio-Medical Materials and Engineering, Pergamon Press,
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`from 1990-1996.
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`11.
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`I have published over 95 journal articles, book chapters, symposia,
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`research papers and patents, most of which relate to biomaterials and spinal
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`implants. My patents include U.S. Patent Nos. 6,669,732, entitled “Spinal Disc”,
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`6,162,252, entitled “Artificial Spine Disc,” 5,824,094, entitled “Spinal Disc.”
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`12.
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`I have authored or co-authored over 75 presentations with published
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`abstracts for national and international meetings all over the world, mostly relating
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`to biomaterials.
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`13. A full list of my publications, patents, book chapters, and conference
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`presentations is included in my Curriculum Vitae (Ex. 1003).
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`14. Exhibit 1004 is a list of the documents that I have considered in
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`forming my opinions provided in this report. I reserve the right to supplement my
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`opinions in the future to respond to any arguments that the Patent Owner raises and
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`to take into account new information as it becomes available to me.
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`
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` OVERVIEW OF THE ’531 PATENT II.
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`15. The ‘531 patent specification provides a method and apparatus
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`4
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`5 of 48
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`
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`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
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`for changing a spatial relationship between adjacent
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`bones by inserting a wedge member into the joint
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`between the bones. (Ex. 1001 at 1:48-50.) As
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`depicted in Figure 2 of the ‘531 patent, the wedge
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`member applies a force to the adjacent bones as it is
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`moved into the joint, thus changing the spatial
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`relationship between the bones. (Id. at 1:52-56;
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`2:42-45; Fig. 2.) The ‘531 patent specification
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`states that the wedge member can be used with any
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`
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`joints in a patient’s body, including intervertebral
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`joints. (Id. at 2:27-28.)
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`16. The ‘531 patent specification describes various implantable wedge
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`members. For example, the wedge member may have a sharp leading edge as
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`depicted above, or, as depicted in Figure 12 of the ‘531 patent (Id. at 13:60-66;
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`Fig. 12.) The ‘531 patent provides that when the apparatus is used to change a
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`spatial relationship between bones which are interconnected at a joint in a patient’s
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`body, an opening is first formed in a portion of the patient’s body to expose the
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`joint interconnecting the bones. (Id. at 1:50-52.) Then one of the bones is moved
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`relative to the other by expanding at least a portion of the joint with a wedge
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`member. (Id. at 1:52-54.) The wedge is subsequently moved into the joint and
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`5
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`6 of 48
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`
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`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
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`applies force against the bones wherein the force is then transmitted between the
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`bones through the wedge member to maintain the joint in an expanded condition.
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`(Id. at 1:54-59.)
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`17. The ‘531 patent specification describes various implantable wedge
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`members. In one disclosed embodiment depicted
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`in Figure 5 of the ‘531 patent, the wedge member
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`has upper and lower major side surfaces that slope
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`towards each other and intersect at the thin end.
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`(Id. at 6:40-43.) The ‘531 patent contemplates that
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`
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`a plurality of wedge members have different acute angles between the upper and
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`lower major side surfaces to enable a surgeon to select the wedge member having a
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`desired thickness at the thick end portions after the surgeon determines to what
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`degree the joint should be expanded. (Id. at 6:43-52.)
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`18. The ‘531 patent specification further describes an embodiment of a
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`wedge member that is porous and/or has passages extending between the upper and
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`lower surfaces in order to allow bone to grow through it. (Id. at 10:1-8; Fig. 9.)
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`6
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`7 of 48
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`
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`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
`
`
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`19. The ‘531 patent specification further describes an embodiment of a
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`hollow wedge member with a compartment. (Id. at 11:11-20.) The compartment,
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`the ‘385 patent explains, has upper and lower inner side surfaces which are smaller
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`than the upper and lower major side surfaces of the wedge member. (Id. at 11:14-
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`17.) The inner side surfaces, however, have the same general configuration as the
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`upper and lower major side surfaces of the wedge member. (Id. at 11:17-20.)
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`20. The ‘531 patent further describes that the compartment is filled with
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`bone growth inducing material. (Id. at 11:21-22.) The ‘531 patent provides that
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`the bone growth inducing material is positioned in the compartment through a
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`suitable opening formed in either the upper major side surface or the lower side
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`surfaces of the wedge member. (Id. at 11:22-26.) The specification provides
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`examples of bone growth inducing materials to include bone morphogenic
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`proteins and osteoinductive materials such as apatite compositions with collagen
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`
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`7
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`8 of 48
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`
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`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
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`and demineralized bone. (Id. at 33-38.)
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`21. The ‘531 patent issued with 129 claims of which independent claim
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`105 is the only claim at issue in the Synthes Petition. Challenged Claim 105 is
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`directed to “[a]n apparatus for use in changing the spatial relationship between first
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`and second bones which are interconnected at a joint in a patient's body, said
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`apparatus comprising a wedge member which is movable into the joint between the
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`first and second bones, said wedge member having a thin end portion, a thick end
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`portion, a first major side surface which extends from said thin end portion to said
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`thick end portion, a second major side surface which intersects said first major side
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`surface to form an edge at said thin end portion and extends from said thin end
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`portion to said thick end portion, and a minor side surface which extends between
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`said first and second major side surfaces and tapers from said thick end portion to
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`said thin end portion, said wedge member having a plurality of passages which
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`extend between said first and second major side surfaces for enabling bone to grow
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`through said wedge member. (Id. at claim 105.)
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`
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` CLAIM CONSTRUCTION III.
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`22.
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`I understand that for inter partes review, claim terms are presumed to
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`have their ordinary and customary meaning, unless the patent provides its own
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`definition, and that claim terms will be given their broadest reasonable
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`interpretation in view of the patent specification.
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`8
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`
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`9 of 48
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`
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`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
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`23. Challenged Claim 105 is directed to an apparatus comprising a wedge
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`member. The body of the claim contains the recitation that the wedge member “is
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`movable into the joint between the first and second bones.” I understand from
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`counsel that an apparatus claim, such as Challenged Claim 105, covers what a
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`device is, not what a device does. Therefore, I understand that all of the limitations
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`of Challenged Claim 105 are present in a prior art reference that teaches each of
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`the claim’s structural limitations.
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` TECHNICAL BACKGROUND IV.
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`
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` Anatomy of the Spine A.
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`24. The ‘531 patent is generally directed to an implantable wedge-shaped
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`device used for changing the spatial relationship between bones in the human
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`body. A person of ordinary skill in the art would have understood that the field of
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`such devices would include at least devices used in osteotomy and spinal fusion
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`procedures.
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`25. Osteotomy is the surgical practice in which a bone is cut to shorten,
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`lengthen, or to change its alignment (e.g. to correct the shape of deformed bones).
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`To change the alignment, the surgeon can either cut out and remove a wedged
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`piece of bone and close the opening (a closing wedge osteotomy) or can insert a
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`wedge shaped piece of bone or implant into the opening (an opening wedge
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`osteotomy). In a closing wedge osteotomy, the resulting site has bone on bone
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`9
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`10 of 48
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`
`
`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
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`contact and can fuse directly. In an opening wedge osteotomy, the wedge shaped
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`implant can be filled with bone marrow, bone chips or other bone inducing
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`materials to promote bone formation and fusion. This procedure was well-known
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`to a person of ordinary skill in the art as of August 20, 1998.
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`26. The spine extends from the base of the skull to the tail bone or coccyx
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`and consists of bones called vertebrae. Each vertebrae is separated from the
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`adjacent vertebrae, either above or below, by an intervertebral disc that consists of
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`an outside annulus made primarily from collagen fiber and an inside made of a gel
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`like material. The top and bottom of the disc space are the adjacent vertebral
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`bodies. The vertebral bodies are bony structures with a softer and vascular
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`cancellous bone interior and a harder cortical bone shell. There are 23
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`intervertebral discs in the human body: six in the cervical region (i.e., neck), 12 in
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`the thoracic region (i.e., middle back), and five in the lumbar region (i.e., lower
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`back), which includes the disc between the lowest lumbar vertebral body (L5) and
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`the top of the sacrum (S1). The intervertebral discs of the spine provide flexibility
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`and some cushion from shock. The flexibility includes flexion (bending forward),
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`extension (bending backward), and lateral bending (bending sideways), with
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`different ranges of motion for each level of the spine.
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`27.
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`In a normal standing position, the spine is not straight, but has a
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`curved nature. The normal curvature of the normal spine consists of lordosis
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`10
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`11 of 48
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`
`
`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
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`(segments creating a backward leaning curve) in the cervical region, kyphosis
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`(segments creating a forward leaning curve) in the thoracic region and lordosis
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`again in the lumbar region and is generated by both wedge shaped vertebral bodies
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`and wedge shaped spinal discs.
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`
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`The wedge shape of the spinal discs is different at different levels of the spine. For
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`example, both the lumbar disc space of L4-L5 (the most commonly operated
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`lumbar disc space between vertebral body L4 and vertebral body L5) and the disc
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`space L5-S1 (the second most commonly operated lumbar disc space between
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`vertebral body L5 and the top of the sacrum, S1) have been reported to have a
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`normal angle of 11 degrees of lordosis.1 Cervical disc spaces are typically between
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`1 Wambolt A, Spencer DL, “Analyses of the Distribution of the Lumbar Lordosis
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`11
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`12 of 48
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`
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`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
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`2 degrees to 10 degrees of lordosis.2 The loss of normal lordosis causes pain as
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`muscles and joints are put under stresses for which they were not designed.
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`28. The overall curved shape of the spine is important. However, the
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`spine can become damaged as a result of degeneration, dysfunction, disease,
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`trauma, and age. In patients with spine degeneration, the spine may exhibit
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`abnormal curvature, abnormal alignment of the vertebrae and/or general deformity
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`due to the thinning or collapse of the spinal discs. These conditions may lead to
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`nerve compression, disability and overall instability and pain. Surgical
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`intervention may be required to correct spinal anomalies and may involve
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`realigning of vertebrae and/or stopping the motions that generate pain (e.g. by
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`fusion) or creating more normal motions (e.g. by functional artificial spinal discs).
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`29. One medical condition sometimes resulting from degeneration of the
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`spine or scoliosis is flat back syndrome. In patients with flat back syndrome, the
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`normal lordosis curvature of the spine is lost and the patients need to bend forward
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`
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`in the Normal Spine. 11(1) ORTHOP TRANS. 92-3 (1987) (the L1-L2 disc space has
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`also been reported to have an angle of 6 degrees of lordosis).
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`2 Lu J et al., “Anatomic Bases for Anterior Spinal Surgery: Surgical Anatomy of
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`the Cervical Vertebral Body and Disc Space,” 21(4) SURG. RADIOL. ANAT.
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`235-39 (1999)
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`
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`12
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`13 of 48
`
`
`
`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
`
`in order to stand upright. Over time, this abnormal posture causes pain as muscles
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`and joints are put under stresses for which they were not designed. Surgeries are
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`sometimes conducted to restore the normal curvature of the spine. 3
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`30. A common treatment for a variety of spinal disorders is spinal fusion.
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`Spinal fusion combines two vertebral bodies and the intervening disc into one large
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`bone. A spacer such as a fusion cage or an allograft is most often used to assure
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`that there is room in the center of the now fused together vertebral bodies for the
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`nerves to exit from the spinal cord to the rest of the body without being crushed.
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`Where spinal fusion occurs in a section of the spine with significant lordosis, the
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`normal curvature of the spine in that area is typically restored.
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`31.
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`Intervertebral implants in these curved regions of the spine are
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`therefore typically wedge-shaped to restore and maintain lordosis, the normal
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`curvature of the spine. Wedge-shaped cages significantly increase segmental
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`lordosis, enhance lumbar lordosis, and are preferred for restoring sagittal alignment
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`in instrumented posterior lumbar interbody fusion procedures.4
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`
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`3 Kostuik JP et al., “Combined Single Stage Anterior and Posterior Osteotomy for
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`Correction of Iatrogenic Lumbar Kyphosis,” 13(3) SPINE 257-66 (Mar. 1988).
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`4 Gödde S et al., “Influence of Cage Geometry on Sagittal Alignment in
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`Instrumented Posterior Lumbar Interbody Fusion,” 28(15) SPINE 11693-99 (Aug.
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`
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`13
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`14 of 48
`
`
`
`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
`
`
`B.
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`Spine Fusion Was A Common Procedure in 1998
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`32. As of August 20, 1998, the use of spinal implants to stabilize and fuse
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`vertebrae to relieve pain and correct deformities in patients with various forms of
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`spinal degeneration was common practice. As early as the 1950s, decompression –
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`the removal of the intervertebral disc located between adjacent vertebrae – together
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`with the implantation of a bone graft in the resulting space had been established as
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`a standard method of accomplishing stabilization and fusion.5
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`33. Between 1990 and 1998, over one million spinal fusions were
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`performed in hospitals throughout the U.S. Of the 112,000 spinal fusions
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`performed in U.S. hospitals in 1990, 50% were cervical fusions, 35% were lumbar
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`9% were thoracic, and 6% were for refusions or unspecified. In 1998, over
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`174,000 spine fusions were performed.6
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`C.
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`Spinal Implant Design and Spinal Implant Materials
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`
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`1, 2003).
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`5 Cloward RB, “The Treatment of Ruptured Lumbar Intervertebral Discs by
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`Vertebral Body Fusion,” 10(2) J. NEUROSURGERY 154-68 (March 1953).
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`6 "Spinal Implants: The Next Orthopedic Growth Market," 3 (3) Orthopedic
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`Network News 1-5 (July 1992); Rajaee, SS, et al., “Spinal Fusion in the United
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`States, Analysis of Trends From 1998 to 2008,” 37(1) SPINE 67-76 (2012).
`
`
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`14
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`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`15 of 48
`
`
`
`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
`
`34. As of August 20, 1998, spinal implants had long been designed in a
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`variety of shapes and sizes to fit the specific implantation site and to accomplish
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`the needed correction, and manufactured in a variety of materials.
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`35. For example, it was common to provide wedge-shaped intervertebral
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`disc replacements with a variety of angles to match the natural disc angles so as to
`
`restore and maintain lordosis. For cervical spine implants, such implants may be
`
`longer than they are wide or wider than they are long – depending on surgeon
`
`preference on how much bone to remove on the sides. For lumbar spine implants,
`
`such implants are commonly wider than they are long. Moreover, some implants
`
`were designed with a thick wall between the anterior face and a central opening in
`
`order to provide additional material for inserter tools to hold the implant and more
`
`strength to allow the implant to be inserted and adjusted within the disc space. The
`
`thicker wall also provides more surface area to contact the hard cortical bone of the
`
`anterior sides of the superior and inferior vertebrae for load bearing and to inhibit
`
`subsidence.
`
`36. Furthermore, spinal implants designed to fuse two vertebrae typically
`
`contained one or more passages for insertion of bone graft material through which
`
`bone growth could occur. The illustration below shows a wedge-shaped vertical
`
`ring implant with two openings for bone graft material that was in use in the early
`
`
`
`15
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`16 of 48
`
`
`
`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
`
`1990s.7 As seen, the central rib reduces the amount of bone graft that can be used,
`
`but provides more surface area to help resist subsidence, strengthens the implant
`
`and provides additional material for the anterior face screw hole for the inserter.
`
`Fig. 2 of Weiner
`
`
`
`37. Michelson also discloses an opening for bone graft material. (U.S.
`
`Patent No. 5,609,635 (“Michelson”).) Michelson discloses an interbody spinal
`
`fusion implant configured to restore and maintain two adjacent vertebrae of the
`
`spine to correct anatomical angular relationship. (Id. at 1:18-21.) Specifically,
`
`Michelson discloses that the spinal fusion implants have a structural configuration
`
`that provides for the maintaining and creating of the normal anatomic angular
`
`relationship of two adjacent vertebrae of the spine to maintain and create spinal
`
`
`
`7 Weiner BK and Fraser RD, “Spine Update Lumbar Interbody Cages,” 23(5)
`
`SPINE 634-640 (1998).
`
`
`
`16
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`17 of 48
`
`
`
`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
`
`lordosis. (Id. at 1: 57-61.) The spinal fusion implants have upper and lower
`
`surfaces that are in a converging angular relationship to each other such that the
`
`implants have an overall wedge-shaped. (Id. at 2: 1-5.) Michelson further teaches
`
`that the implant is hollow and comprises a plurality of openings passing through
`
`the upper and lower surfaces and into a central hollow chamber. (Id. at 6: 56-59.)
`
`The internal hollow chamber can be filled with osteoconductive, osteoinductive,
`
`osteogenic and other fusion enhancing materials such as bone or bone growth
`
`inducing material such as hydroxyapatite, hydroxyapatite tricalcium phosphate or
`
`bone morphogenic protein. (Id. at 7: 19-25.)
`
`38. Pavlov discloses a wedge-shaped fusion cage that is shaped by the
`
`normal lordosis of the vertebral bone structures and the conically-shaped body can
`
`be sized and selected in order to maintain or enlarge upon the normal lordosis.
`
`(U.S. Patent No. 5,906,616 (“Pavlov”), 2:9-16.) Pavolv provides that the fusion
`
`cage has an internal cavity wherein bone growth inducing substances, such as
`
`bone chips, can be placed either before the fusion cage is inserted or after the
`
`fusion cage is inserted. (Id. at 2:62-66.)
`
`39. Stainless steel has long been used for implants and since the early
`
`1990s, additional metals such titanium became more common. A problem with
`
`metals, however, is that they inhibit imaging by blocking x-rays and cause
`
`imaging artifacts by bending magnetic fields. This makes post-operation
`
`
`
`17
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`18 of 48
`
`
`
`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
`
`assessment of fusion or tumor recurrence more difficult. In addition, the very
`
`high stiffness of metals means that metallic implants carry almost all of the
`
`mechanical loads from the top surface of the implant to the bottom surface of the
`
`implant and do not allow the surrounding bone to flex, bend, or compress. This
`
`discourages bone growth and hence fusion.
`
`40. Also in the early 1990s, therefore, polymeric materials (biocompatible
`
`plastics) were put to use for orthopedic applications. Commonly used polymeric
`
`materials at this time include poly(ether ether ketone) (PEEK) and poly(ether
`
`ketone ether ketone ketone) (PEKEKK), and carbon fiber filled forms of these
`
`polymers, and were used since the early 1990s for interbody fusion cages.
`
`41. Because the bone growth necessary for spinal fusion occurs best when
`
`the bone is under a dynamic load, compressible implants are optimal for promoting
`
`spinal fusion. Certain polymeric materials were known to be both rigid and strong
`
`enough to support a patient’s weight and compressible so as to encourage fusion.
`
`42.
`
`Polymeric materials were both radio translucent and less stiff than
`
`metals. Polymeric materials also permit assessment of fusions using radiographs,
`
`computed tomography scans or magnetic resonance imaging.
`
`
`D.
`
`Fixation of Spine Implants
`
`43. By 1998 it had long been understood that spinal fusion implants must
`
`be fixed in place between vertebrae in order for fusion to occur. With the anterior
`
`
`
`18
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`19 of 48
`
`
`
`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
`
`longitudinal ligament and the disc annulus cut, the forces applied on the implanted
`
`device by the spine could otherwise move the implant out of place or even eject it
`
`from the cavity. Even local micromotion at the interface of the implant and the
`
`bone must be minimized for fusion to occur. Fixing the implant in place also
`
`maintains the alignment of the spine around the implant.
`
`44. The earliest and most common method of fixation was the use of
`
`screws. One early method was using two cancellous bone screws and washers to
`
`secure a wedge-shaped intervertebral implant to the vertebrae.
`
`45. Another common fixation method was screwing a metal plate, strip or
`
`rod to the vertebrae as shown below:8
`
`Figure 11 of U.S. Patent No. 4,743,256
`
`46. Metal was a preferred material for fixation components due to its high
`
`
`
`strength and stiffness.
`
`
`
`8 U.S. Patent No. 4,743,256.
`
`
`
`19
`
`DePuy Synthes Products, Inc. & DePuy Synthes Sales, Inc.
`Exhibit 1002
`20 of 48
`
`
`
`Declaration of Carl R. McMillin, Ph.D., in Support of DePuy Synthes Sales, Inc.
`and DePuy Synthes Products, LLC Petition – IPR of U.S. Patent No. 6,099,531
`
`47. For example, Doty discloses a vertebral body prosthesis made of a
`
`bio-compatible material such as metal or plastic that approximates the dimension
`
`of one human vertebral body. (U.S. Patent No. 4,599, 086 (“Doty”), 3:15-18.)
`
`Doty also discloses that the prosthesis has a biocompatible metal retaining plate
`
`which overlaps two vertebral bodies and is secured via screws to fasten the plate to
`
`the bony structure of the vertebral bodies. (Id. at 4:49-58.) Doty further discloses
`
`that the prosthesis contains a spacer member in a variety of different widths to
`
`accommodate different spinal configurations with each spacer measuring various
`
`fractions of a vertebral body and/or vertebral interspace. (Id. at 5: 6-10.)
`
`48. Salib also discloses a method of fixation. (U.S. Patent No. 5,258,031
`
`(“Salib”).) Salib discloses a surgical joint replacement device for replacement of a
`
`ruptured disk between consecutive vertebrae in the spine. (Id. at 1:8-10.) Salib
`
`states that the device has an upper assembly and a lower assembly (id. at 3:22-23)
`
`and is to be implanted between a first vertebral body above it and a second
`
`vertebral body below it (id. at 3:15-18). The upper assembly includes a first
`
`member having a socket (id. at 3:24-25) while the lower assembly includes a
`
`second member having a ball that fits loosely into the socket of the upper assembly
`
`(id. at 3:46-48). Salib describes that the first and second members have a base
`
`plate with a tab that includes an opening therethrough so that a screw can be used
`
`to fasten the assembly t
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